Status:
COMPLETED
Rasburicase for Hyperuricemia
Lead Sponsor:
Sanofi
Conditions:
Nutritional and Metabolic Diseases
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
Brief Summary
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentratio...
Eligibility Criteria
Inclusion
- \<18 years of age
- Patient with newly diagnosed hematological malignancies presenting with hyperuricemia:
- Uric acid \> 7.5 mg/dL in patients ≥ 13 years old- Uric acid \> 6.5mg/dL in patients \<13 years old
- Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:
- Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,
- Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following:
- At least one lymph node or mass \>5 cm in diameter
- LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification
- Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc.
Exclusion
- Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period.
- Low birth weight infant (\<2500g) or gestational age \<37 weeks
- Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period.
- Known history of severe allergic reaction and/or severe asthma.
- Known history or family history of glucose-6-phosphate dehydrogenase deficiency.
- Known history of hemolysis and methemoglobinemia.
- Severe disorders of liver or kidney. ALT (GPT) \> 5.0 x ULN, Total Bilirubin \> 3.0 x ULN, Creatinine \> 3.0 x ULN
- Uncontrollable infections (including viral infections).
- Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00290992
Start Date
June 1 2005
End Date
April 1 2006
Last Update
March 30 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan